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BCS

Current Report · Items 2.02, 7.01, 9.01 · 8-K

Harmony Biosciences Holdings, Inc.

HRMYNASDAQEQUITYCurrent

Results of Operations and Financial Condition · Regulation FD Disclosure

Item 2.02. Results of Operations and Financial Condition. On May 7, 2026, Harmony Biosciences Holdings, Inc. (the “Company”) issued a press release announcing its financial results for the quarter ended March 31, 2026. A copy of this press release is attached as Exhibit 99.1 to this Current Report on Form 8-K and is incorporated herein by reference.

Filed May 7, 2026Accepted May 7, 2026, 9:24 AM EDTCIK 1802665Accession 0001104659-26-056786
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Company context

Harmony Biosciences is a pharmaceutical company dedicated to developing and commercializing innovative therapies for patients with rare neurological diseases who have unmet medical needs. Driven by novel science, visionary thinking, and a commitment to those who feel overlooked, Harmony Biosciences is nurturing a future full of therapeutic possibilities that may enable patients with rare neurological diseases to truly thrive. Established by Paragon Biosciences, LLC, in 2017 and headquartered in Plymouth Meeting, Pa., we believe that when empathy and innovation meet, a better future can begin; a vision evident in the therapeutic innovations we advance, the culture we cultivate, and the community programs we foster. For more information, please visit www.harmonybiosciences.com.

Current securities

Recent company filings

  1. Departure of Directors or Certain Officers; Election of Directors; Appointment of Certain Officers; Compensatory Arrangements · Regulation FD DisclosureOct 13, 2026
  2. 144 filingAug 7, 2026
  3. 10-Q filingAug 4, 2026
  4. Results of Operations and Financial Condition · Regulation FD DisclosureAug 4, 2026
  5. SCHEDULE 13G - filed by VANGUARD PORTFOLIO MANAGEMENT LLC regarding Harmony Biosciences Holdings, Inc.Jul 31, 2026

Disclosure sections

Items 2.02, 7.01, 9.01

Select an item to read the extracted section. The as-filed document remains the primary evidence.

Item 2.02Item 2.02 - Results of Operations
Item 2.02. Results of Operations and Financial Condition. On May 7, 2026, Harmony Biosciences Holdings, Inc. (the “Company”) issued a press release announcing its financial results for the quarter ended March 31, 2026. A copy of this press release is attached as Exhibit 99.1 to this Current Report on Form 8-K and is incorporated herein by reference.
Item 7.01Item 7.01 - Regulation FD Disclosure
Item 7.01. Regulation FD Disclosure. On May 7, 2026, the Company posted an investor presentation to its website at ttps://ir.harmonybiosciences.com (the “Investor Presentation”). A copy of the Investor Presentation is attached as Exhibit 99.2 to this Current Report on Form 8-K and is incorporated herein by reference. The Company expects to use the Investor Presentation, in whole or in part, and possibly with modifications, in connection with presentations to investors, analysts and others. The information contained in the Investor Presentation is summary information that is intended to be considered in the context of the Company’s Securities and Exchange Commission (“SEC”) filings and other public announcements that the Company may make, by press release or otherwise, from time to time. The Investor Presentation speaks only as of the date of this Current Report on Form 8-K. The Company undertakes no duty or obligation to publicly update or revise the information contained in the Investor Presentation, although it may do so from time to time. Any such updating may be made through the filing of other reports or documents with the SEC, through press releases or through other public disclosure. In addition, the exhibit furnished herewith contains statements intended as “forward-looking statements” that are subject to the cautionary statements about forward-looking statements set forth in such exhibit. By furnishing the information contained in the Investor Presentation, the Company makes no admission as to the materiality of any information in the Investor Presentation that is required to be disclosed solely by reason of Regulation FD. This Current Report on Form 8-K and its contents (including Exhibits 99.1 and 99.2) are furnished and shall not be deemed “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, as amended (the “Exchange Act”), or otherwise subject to the liabilities of that section or Sections 11 and 12(a)(2) of the Securities Act of 1933, as amended (the “Securities Act”), nor shall it be deemed incorporated by reference in any filing under the Securities Act or the Exchange Act, regardless of any general incorporation language in such filing, except as shall be expressly set forth by specific reference in such filing. Note Regarding Forward-Looking Statements Certain statements in this Current Report on Form 8-K constitute “forward-looking statements” within the meaning of the federal securities laws. These statements are based on management’s current opinions, expectations, beliefs, plans, objectives, assumptions or projections regarding future events or future results. These forward looking statements are only predictions, not historical fact, and involve certain risks and uncertainties, as well as assumptions. Actual results, levels of activity, performance, achievements and events could differ materially from those stated, anticipated or implied by such forward-looking statements. While the Company believes that its assumptions are reasonable, it is very difficult to predict the impact of known factors, and, of course, it is impossible to anticipate all factors that could affect actual results. There are many risks and uncertainties that could cause actual results to differ materially from the forward-looking statements made herein including the risks discussed under the heading “Risk Factors” in the Company’s Annual Report on Form 10-K for the year ended December 31, 2025, which was filed with the Securities and Exchange Commission (“SEC,”) on February 24, 2026, as well as other factors described from time to time in the Company’s filings with the SEC. Such forward-looking statements are made only as of the date of this Current Report on Form 8-K. The Company undertakes no obligation to publicly update or revise any forward-looking statement because of new information, future events or otherwise, except as otherwise required by law. If it does update one or more forward-looking statements, no inference should be made that the Company will make additional updates with respect to those or other forward-looking statements.
Filed exhibits (2)
EX-99.1 (by filename) hrmy-20260507xex99d1.htm

EX-99.1 2 hrmy-20260507xex99d1.htm EX-99.1 Exhibit 99.1 HARMONY BIOSCIENCES REPORTS Q1 FINANCIAL RESULTS AND CONFIRMS 2026 NET REVENUE GUIDANCE OF OVER $1 BILLION; REINFORCES 2026 STRATEGIC PRIORITIES WAKIX® Net Revenue Grew 17% to $215.4 Million for First Quarter 2026; On Track for Full Year 2026 Net Revenues over $1 Billion Continue to Vigorously Protect WAKIX IP into 2030; Filed Suit Against AET Pharma/Sandoz Regarding Infringement of Amorphous Pitolisant Patent Lifecycle Management Advancing with Pitolisant GR on Track for NDA Filing 2Q26, Pitolisant HD Phase 3 Data in 2027, and Recently Acquired Novel Amorphous Form of Pitolisant to Pursue Broader CNS Indications Potential Best-in-Class Orexin-2 Agonist with BP-205; Phase 1 Clinical PK Data On Track for Mid-2026 Renewed Focus on Business Development Opportunities with Emphasis on Revenue Potential in the 2028 to 2032 Timeframe Expansion of the Leadership Team with the Addition of New COO and CFO to Support Scale and Next Phase of Growth Conference Call and Webcast Today at 8:30 a.m. ET PLYMOUTH MEETING, Pa., May 7, 2026 /Business Wire/ -- Harmony Biosciences Holdings, Inc. (Nasdaq: HRMY) today reported Q1 2026 rev…

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EX-99.2 (by filename) hrmy-20260507xex99d2.htm

EX-99.2 3 hrmy-20260507xex99d2.htm EX-99.2 Copyright © 2026 Harmony Biosciences. All rights reserved. Q1 2026 Financial Results and Business Update May 7, 2026 ────────────────────────────────────────────────────────────── Forward-Looking Statements This presentation contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. All statements contained in this press release that do not relate to matters of historical fact should be considered forward-looking statements, including statements regarding our full year 2026 net product revenue, expectations for the growth and value of WAKIX, plans to submit an NDA for Pitolisant GR; plans to submit an IND for BP-205; our future results of operations and financial position, business strategy, products, prospective products, product approvals, the plans and objectives of management for future operations and future results of anticipated products. These statements are neither promises nor guarantees, but involve known and unknown risks, uncertainties and other important factors that may cause our actual results, performance or achievements to be materially differ…

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